Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

NCT06910579 | Recruiting Phase 2

• 1 other identifier: britishUE1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Interventions of both groups: Oxygenated gel Group: 15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days. Triamcinolone acetonide Group: 15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group. Patients in both groups were reexamined after treatment at different intervals (day 3, day 5, day 7, and day 10).

Conditions

Aphthus Ulcer

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Visual Analog Scale (0-10), which measured a range of "no pain" to "unbearable pain" on a 100 mm horizontal line \[10\]. to determine the intensity of pain on day 0, day 3, day 5, day 7, and day 10

  10 days

Secondary Outcomes (3)

• Size of ulcers (in mm)

  10 days

• Complete healing duration

  10 days

• OHIP-14

  10 days

Study Arms (2)

control

ACTIVE COMPARATOR

15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.

Drug: topical application of Triamcinolone acetonide gel

Oxygenated gel Group

EXPERIMENTAL

15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days

Drug: topical application of oxygenated gel

Interventions

topical application of oxygenated gel DRUG

patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days

Oxygenated gel Group

topical application of Triamcinolone acetonide gel DRUG

patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.

control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤6 mm in size in the oral cavity and who gave written consent for participation.
• Only single ulcers were considered for the study.
• Systemically healthy patients.

You may not qualify if:

• The study excluded patients with a history of associated systemic disease.
• Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous aphthae, and smoking.
• Patients with a history of hypersensitivity to the used agents.
• Pregnancy and lactation

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

British University in Egypt

Al Sherouk City, Cairo Governorate, 11837, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: March 15, 2025
• Primary Completion: January 30, 2026
• Study Completion: April 12, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)